Trans folks: Perrigo updated the FDA drug shortage database today, and have release plans in October and November for 20 and 40 mg/mL doses.
I'm not sure what you mean by the FDA being a roadblocker. They have little to do with the situation.
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Perrigo claims they have supply to distribute but can't until they receive FDA Approval.
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If they changed manufacturers, process, or components, then there are regulatory hurdles, but that has nothing to do with the drug
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But the drug is already approved and the shortage reason listed is "Inactive Ingredient Shortage". This doesn't require reapproval
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The manufacturer, Luitpold, was approved in 2010, so that's not a barrier either.
End of conversation
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